Pilot study on the safety and efficacy of intravenous natural beta-interferon therapy in patients with chronic hepatitis C unresponsive to alpha-interferon.
BACKGROUND
Since a large fraction of patients affected by chronic hepatitis C do not respond to alpha-interferon therapy, we planned a pilot study of intravenous beta-interferon therapy in Italian patients non responsive to several courses of alpha-interferon.


METHODS
Ten Italian patients with chronic hepatitis C were treated intravenously with beta-interferon to assess the biochemical and virological responses. Each patient received intravenously 6 MU of beta-interferon daily for 7 days a week for a period of 2 months; in responders, this treatment was followed by intramuscular beta-interferon administration 6 MU three times a week for an additional 8 weeks.


RESULTS
All the patients were infected by the genotype 1b of hepatitis C virus and had a high serum concentration of HCV-RNA (4.1 +/- 3.3 x 10(7) copies/ml). During intravenous therapy, 4 patients (40%) showed a complete return to normal of alanino-aminotransferase and 3 cases became HCV-RNA negative. During intramuscular beta-interferon administration, two patients breakthrough. At the end of the follow-up (six months after the end of the treatment) two patients only showed return to normal of alanino-aminotransferase, but one of them remained HCV-RNA positive.


CONCLUSIONS
These results indicate that even genotype 1b of hepatitis C virus can be suppressed by intravenous beta-interferon therapy, as previously described in similar cases in Japan. The rate of sustained biochemical and virologic response was, however, low, suggesting that further studies are needed to define the best regimen to achieve eradication of hepatitis C virus infection.
Mazzoran
L
L
Department of Internal Medicine, University of Trieste, Italy.
Grassi
G
G
Giacca
M
M
Gerini
U
U
Baracetti
S
S
Fanni-Canelles
M
M
Zorat
F
F
Pozzato
G
G
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D016679:Genome, Viral; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000032:analysis; D019698:Hepatitis C, Chronic / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D007262:Infusions, Intravenous; D016898:Interferon-alpha / Q000627:therapeutic use*; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000032:analysis; D012449:Safety; D016896:Treatment Outcome
D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D016898:Interferon-alpha; D012367:RNA, Viral; D016899:Interferon-beta; D000410:Alanine Transaminase